Global Program Safety Lead

#LI-Hybrid

Two roles available

Key Responsibilities:

• Provides expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT) -Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
• Is responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources.
• Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities.
• Is responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues.
• Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members -Contributes to and often leads the development of departmental and functional/business unit goals and objectives.
• Distribution of marketing samples (where applicable)

Key Performance Indicators:

• Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations & procedures -Compliance, consistency and quality of safety deliverables

Essential Requirements:

• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
• 5 years clinical experience postdoctoral
• At least 5 years progressive experience in drug development in a major pharmaceutical company, including 3 years in safety at a medical position
• Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information – to include NDA submission documents
• Strong experience in leading cross-functional, multicultural teams
• Strong experience with (safety or others) issue management
• Strong experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publication
• Strong leadership skills including coaching, motivating, and directing, and fostering teamwork. Ability to develop and maintain effective working relationships with subordinates, superiors and peers

The salary for this position is expected to range between $204,400 and $379,600 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.